Label: PITAVASTATIN CALCIUM- pitavastatin calcium tablet, film coated
- NDC Code(s): 72603-479-01, 72603-480-01
- Packager: NorthStar RxLLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 27, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PITAVASTATIN TABLETS safely and effectively. See full prescribing information for PITAVASTATIN TABLETS. PITAVASTATIN tablets, for ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEPitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric ...
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2 DOSAGE AND ADMINISTRATION2.1 Important Dosage and Administration Information - • Take pitavastatin tablets orally once daily with or without food at the same time each day. • For patients that require a ...
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3 DOSAGE FORMS AND STRENGTHS1 mg: White to off-white, round, bevel edged biconvex film coated tablets debossed with ‘H1’ on one side and ‘P’ on other side. 2 mg: White to off-white, round, bevel edged biconvex film ...
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4 CONTRAINDICATIONSPitavastatin tablets are contraindicated in the following conditions: • Concomitant use of cyclosporine - [see - Drug Interactions (7)] . • Acute liver failure or ...
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5 WARNINGS AND PRECAUTIONS5.1 Myopathy and Rhabdomyolysis - Pitavastatin may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury ...
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6 ADVERSE REACTIONSThe following serious adverse reactions are discussed in other sections of the labeling: • Myopathy and Rhabdomyolysis - [see - Warnings and Precautions (5.1)] ...
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7 DRUG INTERACTIONSTable 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin and instructions for preventing or managing drug ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Discontinue pitavastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin ...
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10 OVERDOSAGENo specific treatment for pitavastatin overdose is known. Contact Poison Control (1-800-222-1222) for latest recommendations. Hemodialysis is unlikely to be of benefit due to high protein ...
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11 DESCRIPTIONPitavastatin tablets for oral use are HMG-CoA reductase inhibitors. The chemical name for pitavastatin calcium is monocalcium bis [(3 ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 92-week carcinogenicity study in mice given pitavastatin, at the maximum tolerated dose of 75 mg/kg/day with systemic maximum ...
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14 CLINICAL STUDIESPrimary Hyperlipidemia in Adults - Study with Atorvastatin (Study 301) Pitavastatin was compared with atorvastatin calcium tablets (referred to as atorvastatin) in a randomized ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGPitavastatin tablets 2 mg are white to off-white, round, bevel edged biconvex film coated tablets debossed with ‘H2’ on one side and ‘P’ on other side. They are supplied as follows ...
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17 PATIENT COUNSELING INFORMATIONMyopathy and Rhabdomyolysis - Advise patients that pitavastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELPitavastatin Tablets 2 mg 90s Container Label - Pitavastatin Tablets 4 mg 90s Container Label
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INGREDIENTS AND APPEARANCEProduct Information